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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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ASI IVD System - 07290016630039

ASI IVD System with software version GenASIs V-8.3
APPLIED SPECTRAL IMAGING LTD.
GenASIs 8.3
In Commercial Distribution

  • 07290016630039 ()


  • Laboratory analyser operation system software IVD

GenASIs™ System - 07290016630015

No Description
APPLIED SPECTRAL IMAGING LTD.
GenASIs
Not in Commercial Distribution

  • 07290016630015 ()


  • Laboratory analyser operation system software IVD

GenASIs™ System - 07290016630008

No Description
APPLIED SPECTRAL IMAGING LTD.
GenASIs
Not in Commercial Distribution

  • 07290016630008 ()


  • Laboratory analyser operation system software IVD

m2000 - 00884999043503

m2000rt SYSTEM SOFTWARE Release 8.0
ABBOTT MOLECULAR INC.
08N89-001
In Commercial Distribution

  • 00884999043503 ()
08N89-001

  • Laboratory analyser operation system software IVD

Remote Network Station - 00851725007290

Remote Network Station with Dell OptiPlex 7490 23.8” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7490
In Commercial Distribution

  • 00851725007290 ()
RNS-6803-7490

  • Centralized patient monitor

Remote Network Station - 00851725007238

Remote Network Station with Dell OptiPlex 7480 23.8” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7480
In Commercial Distribution

  • 00851725007238 ()
RNS-6803-7480

  • Centralized patient monitor

Remote Network Station - 00851725007191

Remote Network Station with Dell OptiPlex 7470 23.8” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7470
In Commercial Distribution

  • 00851725007191 ()
RNS-6803-7470

  • Centralized patient monitor

Remote Network Station - 00851725007184

Remote Network Station with Dell OptiPlex 7460 23.8" All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7460
In Commercial Distribution

  • 00851725007184 ()
RNS-6803-7460

  • Centralized patient monitor

Gentuity - 00859910007049

Gentuity Off-line Review Station includes computer, monitor, keyboard, and mouse.
GENTUITY LLC
Gentuity Review Station
In Commercial Distribution

  • 00859910007049 ()
G80-01

  • Coronary optical coherence tomography system

BriefCase Triage - 07290018052297

BriefCase is a radiological computer aided triage and notification software
AIDOC MEDICAL LTD
23.y.z
In Commercial Distribution

  • 07290018052297 ()


  • Radiology DICOM image processing application software
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